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The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function

This study has been completed.
Sponsor:
Collaborator:
Richmond Pharmacology Limited
Information provided by:
Evotec Neurosciences GmbH
ClinicalTrials.gov Identifier:
NCT00526968
First received: September 7, 2007
Last updated: February 14, 2008
Last verified: February 2008
History of Changes

September 7, 2007
February 14, 2008
September 2007
December 2007   (final data collection date for primary outcome measure)
  • Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks [ Time Frame: 2-hours post dose ] [ Designated as safety issue: No ]
  • Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo [ Time Frame: 2-hours post dose ] [ Designated as safety issue: No ]
  • Performance scores in the cognitive tests [ Time Frame: 2-hours post dose ] [ Designated as safety issue: No ]
  • Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks
  • Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo
  • Performance scores in the cognitive tests
Complete list of historical versions of study NCT00526968 on ClinicalTrials.gov Archive Site
Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs [ Time Frame: Up to 24 hours post dose and 5-7 days post last dose ] [ Designated as safety issue: Yes ]
Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs
Not Provided
Not Provided
 
The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function
A Double Blind, Placebo Controlled Study to Investigate the Role of NMDA Receptor NR2B Subunit Selective Antagonism on Cognitive Functions and Neurophysiology in Healthy Subjects as Measured With MRI

The purpose of this study is to investigate the neurophysiological changes following single doses of EVT 101 using fMRI during rest and during cognitive tasks in young healthy male subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Human Volunteers
  • Drug: EVT 101
    8 mg capsule, single oral dose
  • Drug: EVT 101
    15 mg capsule, single oral dose
  • Drug: placebo
    Placebo capsule, single oral dose
  • Experimental: 1
    EVT 101 8 mg capsule
    Intervention: Drug: EVT 101
  • Experimental: 2
    EVT 101 15 mg capsule
    Intervention: Drug: EVT 101
  • Placebo Comparator: 3
    Matching placebo capsule
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy Male volunteers
  • Body Mass Index between 19 and 29

Exclusion Criteria:

  • Subjects who received any prescribed medication within 5 half lives or 14 days of the first dose administration whichever is the longer
  • Subjects who have received any prescribed CNS medication or any medication known to chronically alter drug absorption or elimination processes within 30 days of first dose administration
  • Participation in a clinical trial of an investigational drug within the past 4 months or of a marketed drug within the past 3 months
  • History of allergy to NMDA antagonists or other clinically significant drug allergy
  • Supine blood pressure and heart rate of higher than 140/90 mmHg and 90 bpm respectively or lower than 80/40 mmHg and 40 bpm
  • Consumption of more than 21 units of alcohol per week or history of alcoholism or drug/chemical abuse
  • Smokers of more than 5 cigarettes or equivalent per day
  • Subjects who cannot complete the neuropsychological test battery
  • Any clinically significant health deficit
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00526968
EVT 101/1002, EudraCT No.: 2007-000986-40
No
Dr Hermann Fuder, Senior VP, Clinical Development, Evotec Neurosciences GmbH
Evotec Neurosciences GmbH
Richmond Pharmacology Limited
Principal Investigator: Nigel Leigh, BSc MBBS Phd Department of Clinical Neurosciences, Institute of Psychiatry
Evotec Neurosciences GmbH
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP